1. Technical Field of the Invention
The present invention relates generally to oxychlorine oral rinse compositions that combine improved palatability and tissue compatibility with the dual ability to reduce oral malodor and eliminate microbial pathogens associated with gum diseases, and methods for the preparation of such compositions.
More particularly, the present invention relates to oxychlorine oral rinse compositions that are effective against oral malodorancy by oxidatively destroying both the chemical species that characterize oral malodorants and the putrefactive microorganisms that create it. The oxychlorine compositions of the present invention comprise both chlorine dioxide and chlorite ion in an optimum ratio for providing supplementary oxidative activity from the complex anion produced therefrom.
2. Description of the Prior Art
Malodor of the oral cavity, and all related terms such as “bad breath,” “halitosis,” “foul breath” and “breath malodor,” generally refer to the offensive breath odor of one person as detected by another. It has been estimated that 90% of the population exhibit oral malodor upon arising (e.g., “morning mouth”) which persists throughout the day in about 20% of American adults. Such oral malodor is often not directly detectable by the sufferer, who only becomes aware by the revealing actions of others. In addition to immediate embarrassment, oral malodor can cause a significant interference with the enjoyment of everyday life, affecting career advancement as well as family and societal relationships.
Contrary to popular belief, at least 90% of the malodors in healthy persons are produced by local oral conditions. Normal lung air and stomach aroma do not significantly contribute to oral malodor, although various localized respiratory infections, organ system diseases, medications and metabolic disorders can cause malodorous breath. The causes of “morning mouth” and the bad breath which lasts through the day are basically the same, i.e., the putrefactive activity of certain oral bacteria on the sulfur-containing amino acids in oral organic matter such as cellular debris, food particles and salivary proteins. This degradation by anaerobic bacteria results in the formation of volatile, odiferous sulfur compounds, consisting primarily of hydrogen sulfide, methyl mercaptan, and to a lesser extent other thiols and disulfides, which are then exhaled in the breath. The products are called by the group term “volatile sulfur compounds” (VSCs) and may be detectable in air at parts per billion levels. In sleep, depleted local oxygen availability, lower salivary flow, and the reduced action of the tongue and cheeks, enhance the action of these bacteria. These effects, however, are overcome by most healthy people in the waking state.
Mouthwash users seem to experience little lasting effect from such use, since these formulations generally act as temporary masking agents that briefly supplant the malodor with a more pleasant one. Such rinses may also wash away some of the organic debris upon which the bacteria thrive, but they cannot eliminate the root cause of the malodor in those who are prone to the condition.
The prior art includes treatments for halitosis whereby the oral cavity is rinsed with an aqueous solution of so-called “stabilized chlorine dioxide.” Examples include U.S. Pat. Nos. 5,200,171; 4,837,009; 4,808,389; 4,793,989; 4,792,442; 4,788,053; 4,786,492; 4,696,811; 4,689,215; 4,851,213; all issued to Perry A. Ratcliff. These patents are all directed to compounds or methods for treating malodors of the mouth, which involve the inaptly termed “stabilized chlorine dioxide.” The expression “stabilized chlorine dioxide” (“SCD”) as used by Ratcliff in his patents, rather than being directed to molecular chlorine dioxide which has been stabilized in some fashion, actually refers to an aqueous solution whose active agent comprises sodium chlorite. Confusion arises because SCD is actually sodium chlorite in solution, which may be formed, for example, by reconverting any chlorine dioxide that is created in a degrading chlorite solution back to chlorite ion, using an oxidant such as hydrogen peroxide. The reaction results in the reduction of the chlorine dioxide to chlorite ion, which can remain in alkaline solutions for extended periods of time. Another method used to produce SCD is to add bulk sodium chlorite to water in combination with a buffer or a peroxy compound, which will stabilize the chlorite and prevent it from slowly converting to chlorine dioxide. In sum, a solution of SCD as described in the art need not contain any significant or even measurable quantities of molecular chlorine dioxide per se, and in reality such solutions are comprised of chlorite salts at alkaline pHs, generally ±pH 9-9.5 (cf. 2% and 5% SCD, as sold by DuPont). The tendency of sodium chlorite to slowly transform to chlorine dioxide, as well as to other inactive chlorine species, is the basis for the claimed activity of SCD solutions in correcting oral malodor. In the Ratcliff patents, for example, the SCD is reported to be present in concentrations which ostensibly produce between 0.05% and 0.1% chlorine dioxide, which corresponds to actual sodium chlorite levels of 0.067% and 0.134% in the solution. The “transformation” to chlorine dioxide is purportedly triggered by acidic microorganisms in the oral cavity, as further mentioned below.
A current, commercially-available composition (ProFresh®) offers effective control of oral mouth odor. Its active ingredient is soluble chlorine dioxide gas, in contrast to the chlorite-based, so-called “stabilized chlorine dioxide”; the basis for other compositions advertised for many years to treat mouth malodor. SCD, as a poor oxidant, is widely considered to be relatively ineffective in controlling oral malodors compared to the dissolved gaseous molecular chlorine dioxide present in the ProFresh® composition. The latter product contains molecular chlorine dioxide, i.e., ClO2, at a level of ca. 40 parts per million (ppm). ClO2 is a good oxidant, although ClO2 solutions are not stable, unless stored under appropriate conditions, and are normally prepared on-site for water disinfection. The ProFresh® product, following ClO2 production by the user, has a useful life of months, owing to its storage in minimally-diffusive polymer containers. Aqueous chlorite (also known as stabilized chlorine dioxide) solutions, which are substantially poorer oxidants, are relatively stable for extended periods at the near-normal pH values of SCD dilutions. SCD will purportedly transform gradually to free (active) ClO2 in an oral environment at much too slow a rate to produce sufficient levels of ClO2 to effectively destroy any significant levels of oral malodorants during the brief contact associated with mouth rinsing.
Oral Microbial Considerations:
These relate to the microorganisms that are responsible for the production of oral malodorants, those responsible for dental plaque and those associated with periodontal disease. With regard to their role in malodor, as mentioned above, the putrefactive activity of certain oral bacteria results in the formation of volatile, odiferous sulfur compounds, such as hydrogen sulfide, methyl mercaptan, and other thiols and disulfides, which are in people's breath. These microorganisms, which primarily reside within tongue surfaces, are anaerobes and facultative anaerobes, which thrive in low oxygen environments.
There is another group of microorganisms, those which are associated with biofilm formation. Dental plaque is a biofilm, and there are about 1,000 species of bacteria that are involved in the formation of dental biofilm. The microorganisms that form the biofilm are mainly the facultative Streptococcus mutans and the true anaerobes, for which examples of such anaerobes include fusobacterium and actinobacteria. Dental plaque forms on both the enamel of the teeth, the surface of the root or dental implants and are embedded in an exo-polysaccharide matrix. The bacteria most frequently associated with periodontal disease in humans, whether biofilm formers or not, are as follows (all classified as Gram-negative pathogens): Actinobacillus actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Bacteroides forsythus, Campylobacter rectus, Treponema spp. and Eubacterium spp (which include both Gram-negative and Gram-positive organisms). While there are a number of antibiotics and antimicrobials (e.g., Doxycycline, chlorhexidine gluconate) which are effective in destroying many of these pathogens, those such as the biofilm-forming Porphyromonas gingivalis pose significant difficulty.
Kross, et al., in U.S. Pat. No. 6,599,432, taught a method for reducing or eliminating microbial flora associated with biofilms in small diameter dental water lines, in which levels of ClO2 of about 500 ppm to about 2,500 ppm were highly effective in penetrating biofilms, and without being vitiated by reaction with the exo-polysaccharide structure of the biofilms, could destroy most, if not all, of the organisms residing therein after a contact time of at least about 30 minutes. This achievement has recently raised the speculation of whether a much smaller concentration of ClO2, at ca. 40 ppm, which is one twelfth the 500 ppm concentration, and with a contact time of perhaps one sixtieth of typical rinse times maximum being generally about 30 seconds), would provide some ability to destroy microorganisms in oral biofilms.
With respect to the ability molecular ClO2 systems to treat oral diseases, such as gingivitis and periodontitis, the literature and prior patent art is silent: Ratcliff in U.S. Pat. No. 4,696,811 teaches the use of SCD for the reduction of dental plaque and the inhibition of the growth of the microorganisms primarily responsible for plaque formation. But reducing plaque formation, if indeed the SCD (chlorite solutions) did show some efficacy in that regard, in no manner provides evidence that it can remediate oral diseases. The composition taught in U.S. Pat. No. 5,281,412 is claimed to provide anti-plaque and anti-gingivitis benefits. The composition comprises chlorite and citrate ion compositions at a pH from about 5.9 to about 6.5. While directed to the antimicrobial control of oral disease conditions, in the defined pH range, little if any ClO2 could be liberated in a timely manner, in that pH range, by the disproportionation of chlorous acid to form it.
Oral Cavity Compatibility:
A number of factors are relevant with regard to the present invention, which incorporates significant discoveries in the use of molecular ClO2 solutions for oral care treatment, for which ClO2 has been well validated as the most effective treatment of oral malodor.                Concentration        Palatability Osmotic Pressure        
Concentration:
The current ProFresh® oral rinse involves the “activation” of a dilute sodium chlorite solution in a two-step process of acidification followed by addition of hypochlorite to create a ClO2 solution of ca. 40 ppm, where there is a large excess of residual chlorite ion. It has been shown by Kross in U.S. Pat. No. 6,284,152, that some excess of chlorite ions in such solutions is decidedly advantageous. The advantage reported in the foregoing patent is that the residual chlorite ion will allow for the continued production of ClO2, after activation and storage of the solution, to compensate for evaporative losses by both periodic opening of the bottle by the consumer and diffusional losses through container walls. This continued slow generation comes about because, at the average pH of the activated solution (ca. 6±0.5), there will be a slow disproportionation of the low level of chlorous acid [HClO2] present in equilibrium with the chlorite ion (from NaClO2) in solution, to create additional ClO2. In the marketed ProFresh® product, the present inventors have calculated that the ratio of chlorite ion to ClO2 after its partial oxidation to ˜40 ppm ClO2 (˜1120−40=1080 ppm chlorite) is ca. 27 [ClO2:ClO2]. In U.S. Pat. No. 6,284,152, Kross teaches that “the molar ratio of chlorite ion to ClO2 in said solutions (should) range from about 20:1 to about 1:1, more preferably about 15:1 to about 1:1, most preferably about 10:1 to about 1:1.” The ratio of 27:1 in the marketed product is therefore above the preferred range and significantly above the most preferred range of about 10:1 to about 1:1. There are several disadvantages attendant to the excess chlorite levels in these solutions which, though they provide continued product uniformity, have a definite negative physiological impact.
Concentration and Perceived and Objectionable “Saltiness” of the Oral Rinse:
With regard to the oral cavity, the compatibility of a chlorite-based oral rinse containing molecular ClO2 as the basis for oral malodor control, these inventors have determined that the absolute and relative levels of chlorite salt, with respect to ClO2 concentration, are substantially inferior to such a system where due consideration is given to that level with regard to taste and osmotic pressure. We have realized that a much reduced level of chlorite ion is required, with respect to the ClO2 level, in order to satisfy both criteria.
Concentration and Incompatibility of the Oral Rinse with Normal Saliva Vis-á-Vis Osmotic Pressure:
With respect to osmotic pressure, this parameter is directly related to the soluble components comprising an aqueous system, as is saliva. A technical publication from Sawinski et al., almost half-a-century ago, reported that the mean osmotic pressure of human saliva is 38 millosmoles/liter (mosm/L), which is mid-range of the 21-77 mosm/L for the subjects in their study. For reference purposes, the osmotic pressure of human blood plasma (which perfuses human tissues) is ˜165 mosm/L. It is desirable, therefore, to devise an oral rinse that would approximate and be optimally compatible with the osmotic pressure of that 21-77 range, and come close to the mean value of 38 in cellular tissue, if possible. The osmotic pressure of the current imbalanced ProFresh product, with a surfeit of chlorite salt, is calculated to be 165 mosm/L, after activation to yield ca., 40 ppm of ClO2. This is approximately 4 times higher than the 38 mosm/L mean osmotic pressure in human saliva. What had to be determined is whether a dilution of the chlorite salt level in the current ProFresh® product, to comport with, or even approximate that lower value of saliva, would be consistent with the continued documented malodorizing functionality of that oral rinse, while concomitantly alleviating much or all of the negative perceived taste of the product.
Oral Pathogens and Biofilms
Oral microbial biofilms, which are implicated in plaque and periodontal disease, are found on such surfaces as the enamel of the teeth, the surface of the root or dental implants. Biofilms are three-dimensional structured bacterial communities attached to a solid surface submerged in, or exposed to some aqueous solution. Biofilms consist of many species of bacteria living within a matrix of excreted polysaccharides, which protect the cells within it. Bacteria living in a biofilm can have significantly different properties from free-floating bacteria, as the dense and protected environment of the film allows them to cooperate and interact in various ways. One benefit of this environment is increased resistance to substances dissolved in saliva, such as antibiotics, since the dense extra-cellular matrix and the outer layer of cells protect the interior of the community.
Dental plaque is a yellowish biofilm that builds up on the teeth. If not removed regularly, it can lead to dental caries. Caries, gingivitis and periodontitis are infectious diseases. One typical study showed that in subgingival plaque the most abundant species from different phyla and species associated with periodontitis were Actinomyces sp., Tannerella forsythia, Fusobacterium nucleatum, Spirochaetes, and Synergistetes. It also identified Lactobacillus spp. in subgingival plaque, and Streptococcus spp. and the yeast Candida albicans in supragingival plaque. These organisms are obviously different from the ones cited earlier that are associated with periodontal disease. What is common to both groups is the biofilm-forming Strep. mutans associated with dental plaque and Porphyromonas gingivalis associated with periodontal disease.
With respect to periodontal disease, it affects one or more of the periodontal tissues, i.e., alveolar bone, periodontal ligament, cementum and gingival. Plaque-induced inflammatory lesions make up the vast majority of periodontal diseases, which are divided into two categories, namely, gingivitis and periodontitis, where gingivitis always precedes periodontitis. Traditionally, the treatment of periodontal disease begins with the removal of subgingival calculus and biofilm deposits. The bacteria responsible for most periodontal disease are anaerobic, and oxygenation reduces, but doesn't eliminate populations. A typical treatment involves the mechanical delivery of hydrogen peroxide to subgingival pockets via a water pick. Another method involves the use of an orally administered antibiotic, Periostat (Doxycycline). While the antibiotic decreases alveolar bone loss and improves the conditions of periodontal disease, is does not kill the bacteria; it only inhibits the body's host response to destroy the tissue. The more recent laser-assisted periodontal therapy has been shown to kill the bacteria that cause periodontal disease, but requires appropriate equipment and dental expertise to practice. Thus, no treatments or even preventive measures exist in the art, providing efficient, rapid and inexpensive control and elimination of periodontal diseases in persons afflicted by, or subject to these conditions. One of the major foci of this invention is the remediation of this situation.
Potential Role of Chlorine Dioxide (ClO2) and Oxychlorine Solutions in the Amelioration of Periodontal Disease
Biofilm control, in such areas as the food industry and in water processing (including dental office water supplies), is often effected using strong oxidizing agents. Although chlorine dioxide (ClO2) is being used increasingly to control microbiological growth in a number of different industries, not much is known about disinfection of biofilms with chlorine dioxide. The unique ability demonstrated by ClO2 to destroy biofilm-encased organisms, as with say chlorine (Cl2), usually used in water purification, is universally attributed to the differing oxidation capacities of both species. As per a citation in an article on ClO2 by the Saber company, a purveyor of ClO2 systems: “Chlorine is a more powerful oxidizer than chlorine dioxide, and will react with a wider variety of chemicals. This property limits its overall effectiveness as a biocide. Conversely, because chlorine dioxide has more oxidative capacity compared to ozone or chlorine, less chlorine dioxide is required to obtain an active residual concentration of the material when used as a disinfectant.” In essence, Cl2 will readily react with the protective carbohydrate-based glycocalyx structure which surrounds the encased micro-organisms, so that much, if not all, of its cidal capacity is vitiated by the time any Cl2 can reach and destroy those organisms. ClO2, on the other hand, has limited reaction with those carbohydrate superstructure components and can more substantially reach the organisms and destroy them. It does so by selective oxidation of more labile amino acids comprising the protein-containing cell walls of the organisms, thereby affecting cell-wall permeability leading to cell death.
In several relevant publications by Szabo et al., one report discussed measuring “ . . . the profiles of chlorine dioxide in a biofilm as a function of depth into the biofilm.” The report continued by stating that the chlorine dioxide microelectrode they used had a linear response . . . up to a ClO2 concentration of 0.4 mM ClO2 (27 ppm) and profiles showed depletion of disinfectant at 100 μm in the biofilm depth, indicating that ClO2 may not reach bacteria in a biofilm thicker than this (100 μm depth) using a 25 mg/l (i.e., a 25 ppm) solution. These findings were consistent with those of Schlafer et al., whose model biofilms matched that of in-vivo-grown dental biofilms, where their thickness (of 7-100 μm) was similar to that of one-day-old human smooth surface plaque. Based upon this information, it would appear that there is a depletion of ClO2 as the gas malodorizing solutions contain ClO2 levels significantly in excess of that 25 ppm (usually 30-40 ppm.) Potentially contributing to this achievement are factors related to the poorly understood dual-species oxychlorine anion, which has been referenced in publications by specialists in fields relating to ClO2 (q.v.)
As mentioned earlier in this Specification, an excess of chlorite ions in the currently marketed ProFresh® solutions has decidedly advantageous aspects. Residual chlorite, post partial conversion to ClO2, allows for a continued subsequent, though incremental, production of ClO2 after activation and storage of the residual chlorite solution, post-conversion. This chlorite reservoir would compensate for any ClO2 evaporative losses by both periodic bottle opening by the consumer and diffusional losses through container walls. The mechanism by which the supplemental ClO2 is created, however, is not by oxidation of the chlorite, from now-consumed hypochlorous acid, but by the slow disproportionation of very low levels of chlorous acid which exist in chlorite solutions at pHs at and below ca. 5-6. That reaction has been well studied, and found to have many pathways, but can be summarized by the following representative equation which occurs in more acidic chlorite solution:4HClO2→Cl−+2ClO2+2H++H2O
At the time of teaching that technology, in Richter, U.S. Pat. No. 5,738,840, there was no apparent realization that the excess of chlorite ion also had a negative drawback, which reportedly detracted from subsequent product sales based on that patent. The disadvantageous aspects of residual unreacted chlorite ion relate negatively to the impact on consumer acceptance (i.e., the organoleptic qualities) of the marketed product, which include the following:
(a) Objectionable “saltiness;”
(b) Hypertonicity, with regard to the relative osmotic pressure of the oral rinse vis-á-vis saliva. It can be seen, from the following chemical consideration of the role of chlorite ion (ClO2−) in aqueous ClO2 solutions, that selecting an optimized level of chlorite ion in such solutions will play an important role in creating the most efficient system with respect to (a) functionality; (b) osmotic compatibility with saliva vis-á-vis oral tissues; and (c) organoleptic acceptability of the appropriately optimized composition. In greater specificity, there should be:                an appropriately sufficient excess of chlorite ion to ensure continued generation and restoration of ClO2, upon evaporative and diffusive losses, but        not to an extent where the excess chlorite salt, e.g., sodium chlorite (a/k/a “stabilized chlorine dioxide”) contributes to an unduly unpleasant, repellant “salty” perception for the product.The Oxychlorine Complex [Cl2O4]−        
There is another major factor to be considered, however, which relates to the enhanced oxidative and germicidal activity of such mixed chlorine dioxide (ClO2)-chlorite (oxychlorine) solutions which, to these inventors' awareness, has heretofore never been reported. This two-species combination in optimized molar ratio concentrations would contribute significantly to the overall success of oral rinse compositions so constructed. This discovery would seem not have been obvious to Richter, in his 840' patent, who taught therein of “oral rinse malodorant solutions comprised of significant levels of molecular chlorine dioxide at a concentration of about 3 ppm to about 200 ppm,” but with no consideration regarding the contributory effect of the chlorite ion or the need for specific levels thereof to ensure the concomitant contribution of the potent oxychlorine complex without untoward negative effects of excess levels. This consideration can be further appreciated in the compositions disclosed by Richter in his 840' patent, e.g., those recited in Claim 1 thereof, which teach “an aqueous solution of molecular chlorine dioxide and a metal chlorite salt, said metal chlorite salt being present in an amount sufficient to maintain said molecular chlorine dioxide at a concentration of about 3 ppm to about 200 ppm.” However, the patent is silent on any reference to the relative amount of chlorite salt to be used to generate the “about 3 ppm to about 200 ppm” of chlorine dioxide, other than specifying in dependent claim 5, “ . . . wherein the metal chlorite salt is present in the solution at a concentration of about 0.01% to about 0.2%” (i.e. about 100 ppm to about 2000 ppm of such salt).
With regard to the Cl2O4− complex anion, it is comprised of one molecule of ClO2 and one of the ClO2− (chlorite) anion. This is a bimolecular association complex [ClO2.ClO2−]− which, according to Masschelein, is an association complex that forms in near neutral aqueous solution [ClO2.ClO2−]−. This [Cl2O4]− complex is also mentioned in Kuhne, U.S. Pat. No. 4,507,285; and Kross, U.S. Pat. No. 6,284,152). “The basis for the stability of the ClO2 in the presence of ClO2− ion appears to derive from the reported existence of a bimolecular charge-transfer complex involving one molecule each of ClO2 and ClO2−, as follows:ClO2+ClO2−[Cl2O4]− Q=1.6 mol−1 
Thus, in solutions that contain both ClO2 and ClO2−, it can be expected that a portion of the ClO2 will be tied up in complex form, and not be available per se as free ClO2. It should be also noted that the oxidation potential of [Cl2O4]− is reported to be actually higher than that of ClO2, so that ClO2 solutions also containing ClO2−, and therefore the complex ion, would be expected to have a greater oxidation capacity than might be expected from simply that calculated from the level of ClO2 present. This increased capacity would be expected to be associated with, for example, greater disinfection or a greater ability to destroy oral malodorants than a comparable ClO2 solution with no additional chlorite present.” (See, also Kross, U.S. Pat. No. 5,820,822) The existence of this oxidizing complex, pairing a non-ionized chlorine dioxide molecule and a chlorite ion, when together in neutral solution, was initially established in publications by Gordon et al., in 1966 and 1972. It is postulated that the basis for this complex formation arises from the fact that the chlorine dioxide molecule is an electron-deficient free radical, and can readily accept the excess electron of the chlorite ion into its molecular orbital, creating a stable dimer, with a more diffuse negative charge. Of course, it should be noted that the Richter '840 patent teaches the presence of chlorite ion in his ClO2 malodorizing compositions, but, as noted above, there is no restriction on the excessive levels of chlorite that they can contain. Further, the '840 patent compositions can teach away from the presence of residual chlorite, sufficient to form the 1:1 composition of both oxychlorine species in [Cl2O4]−.
As noted above, “the oxidation potential of [Cl2O4]− is reported to actually be higher than that of ClO2.” The presence of this species, among the oxychlorine species which comprise the active components of this invention and their methods of preparation probably contributes, to a non-quantifiable degree, to the enhanced, interrelated oxidative and cidal activities of the inventive disclosure. This applies to (a) malodor control; (b) destruction of the causative putrefying organisms; and (c) the cidal activity directed to the variety of oral pathogens associated with periodontal disease (most often encased in protective biofilms).
By way of illustration, using sodium chlorite as the most probable metal chlorite salt, the indicated range of chlorite anion corresponding to the 0.01% to 0.2% (100 ppm to 2,000 ppm) range of metal chlorite salt concentrations would be about 75 ppm to about 1,490 ppm of chlorite anion per se. Accordingly there is no consideration of any required concentrational relationship regarding the chlorite ion in the resulting ClO2-containing solution following its partial oxidation to ClO2, in the taught range of “about 3 ppm to about 200 ppm.” As a matter of fact, if one attempted to practice the prior art, as taught by the '840 patent, the artisan of ordinary skill would immediately note the impossibility of oxidizing, for example, 100 ppm of chlorite ion to form more than 100 ppm of ClO2, despite the designation of “about 200 ppm ClO2” as the claimed upper end of that range.
As noted above, “the oxidation potential of [Cl2O4]− is reported to be actually higher than that of ClO2.” The presence of this species, among the oxychlorine species, which comprise the active components of the present invention and their methods of preparation probably contribute, to a non-quantifiable degree, to the enhanced, inter-related oxidative and cidal activities of the present invention disclosure. This applies to (a) malodor control; (b) destruction of the causative putrefying organisms; and (c) the cidal activity directed to the variety of oral pathogens associated with periodontal disease, which pathogens are most frequently encased in protective biofilms.
Accordingly, the prior art lacks an oxychlorine oral rise composition that adequately contributes to oral care and oral physiology, malodor control and the prevention of periodontal disease.